The role of leukocyte activation in suspected Non-IgE excipient-related COVID-19 vaccine reactions: An exploratory hypothesis-driven study of pathogenesis
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View abstract on PubMed
Summary
This summary is machine-generated.Leukocyte activation (LA) assays measuring responses to lipid excipients in mRNA COVID-19 vaccines may predict adverse reactions. This study suggests LA could be a biomarker for non-immunoglobulin E (IgE) allergic reactions to vaccines.
Area Of Science
- Immunology
- Vaccinology
- Biomarker Discovery
Background
- Adverse allergic reactions to COVID-19 vaccines, including anaphylaxis, have been reported since December 2020.
- Current estimates suggest low rates of anaphylaxis per million mRNA vaccine doses administered.
- The mechanisms underlying mRNA vaccine adverse reactions are debated, with conflicting evidence on the utility of skin testing for excipients like polyethylene glycol (PEG).
Purpose Of The Study
- To explore the role of leukocyte activation (LA) induced by mRNA COVID-19 vaccine lipid excipients in vaccine-associated adverse reactions.
- To investigate the potential of an in-house LA assay as a predictive biomarker for these reactions.
Main Methods
- A proof-of-concept study involving 30 subjects divided into three groups: severe adverse reaction, mild adverse reaction, and asymptomatic (no vaccine).
- Blood samples were analyzed using a leukocyte activation assay to measure responses to five vaccine lipid excipients.
- Leukocyte Activation Index (LAI) scores were categorized as no reaction, moderate, or severe.
Main Results
- Subjects with severe vaccine reactions showed a higher percentage of severe LAI responses (16%) compared to mild reaction (8%) and asymptomatic (4%) groups.
- Moderate LAI responses were also more prevalent in the severe reaction group (24%) than in the mild (18%) and asymptomatic (20%) groups.
- While not definitive, trends suggested a correlation between higher LAI reactivity scores and more severe clinical reactions, particularly with ALC-0159.
Conclusions
- Measurement of LA induced by PEG and other lipid excipients may serve as a novel predictive biomarker for non-IgE mediated allergic reactions to mRNA COVID-19 vaccines.
- The findings highlight concerns regarding non-IgE hypersensitivity reactions and their role in adverse vaccine events.
- Further randomized controlled trials are warranted to explore the potential of LA as a predictive biomarker for vaccine-associated adverse reactions.
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